Efectividad e impacto en la calidad de vida del colirio de ketotifenoResultados del estudio ZETA en pacientes con conjuntivitis alérgica estacional

  1. J Merayo
  2. J Montero
  3. MT Sainz de la Maza
  4. E Fuster
  5. A Lladonosa
Revista:
Archivos de la Sociedad Española de Oftalmologia

ISSN: 0365-6691

Año de publicación: 2003

Volumen: 78

Número: 8

Páginas: 433-441

Tipo: Artículo

DOI: 10.4321/S0365-66912003000800005 DIALNET GOOGLE SCHOLAR lock_openAcceso abierto editor

Otras publicaciones en: Archivos de la Sociedad Española de Oftalmologia

Objetivos de desarrollo sostenible

Resumen

Purpose: To study the effectiveness of ketotifen ophthalmic solution (0.25 mg/ml) in seasonal allergic conjunctivitis (SAC) and the impact on the patient’s quality of life. Methods: A multicentric, longitudinal, prospective study was designed. 284 Spanish ophthalmologists participated recruiting 1145 patients with SAC. After obtaining the informed consent, a drop of ketotifen ophthalmic solution was instilled. At the visit, clinical symptoms pre and post-treatment were assessed. The patients answered a questionnaire of quality of life (QOL) pre-treatment and minimum one week after initiating the treatment. The qualitative variables were described by the percentage, and the quantitative were described by the average, median, standard deviation, and maximum and minimum values. The effectiveness (change of intensity of the symptoms) and the quality of life were studied by the Wilcoxon test with a significance level of 5% (α = 0.05). Results: Following the instillation of the ketotifen ophthalmic solution the intensity of the ocular symptoms (redness, edema, tearing, secretion, photophobia and visual acuity impairment) decreased significantly. Comparing both QOL, we observed a statistically significant reduction of the limitation perceived by the patients in their daily activities, animic state and ocular symptoms. In 0,7% some adverse event was referred, none was serious and only in one case the probable relationship with the drug was specified. Conclusion: The results of the ZETA study demonstrate the tolerability and effectiveness of the ketotifen ophthalmic solution for all the symptoms of SAC in clinical practice, observing improvement in the quality of life of the patient.

Referencias bibliográficas

  • Anderson, DF, MacLeod, JD, Baddeley, SM, Bacon, AS, McGill, JI, Holgate, ST. (1997). Seasonal allergic conjunctivitis is accompanied by increased mast cell numbers in the absence of leucocyte infiltration. Clin Exp Allergy. 27. 1060-1066
  • Rajan, TV, Tennen, H, Lindquist, RL, Cohen, L, Clive, J. (2002). Effect of ingestion of honey on symptoms of rhinoconjunctivitis. Ann Allergy Asthma Immunol. 88. 198-203
  • Strachan, D, Sibbald, B, Weiland, S, Ait-Khaled, N, Anabwani, G, Anderson, HR. (1997). Worldwide variations in prevalence of symptoms of allergic rhinoconjunctivitis in children: the International Study of Asthma and Allergies in Childhood (ISAAC). Pediatr Allergy Immunol. 8. 161-176
  • Juniper, EF, Guyatt, GH, Griffith, LE, Ferrie, PJ. (1996). Interpretation of rhinoconjunctivitis quality of life questionnaire data. J Allergy Clin Immunol. 98. 843-845
  • Juniper, EF, Thompson, AK, Ferrie, PJ, Roberts, JN. (1999). Validation of the standardized version of the Rhinoconjunctivitis Quality of Life Questionnaire. J Allergy Clin Immunol. 104. 364-369
  • Testa, MA, Simonson, DC. (1996). Assesment of quality-of-life outcomes. N Engl J Med. 334. 835-840
  • Bagenstose, SE, Bernstein, JA. (1999). Treatment of chronic rhinitis by an allergy specialist improves quality of life outcomes. Ann Allergy Asthma Immunol. 83. 524-528
  • Ellis, AK, Day, JH, Lundie, MJ. (1999). Impact on quality of life during an allergen challenge research trial. Ann Allergy Asthma Immunol. 83. 33-39
  • Juniper, EF, Guyatt, GH, Ferrie, PJ, King, DR. (1994). Sodium cromoglycate eye drops: regular versus «as needed» use in the treatment of seasonal allergic conjunctivitis. J Allergy Clin Immunol. 94. 36-43
  • Abelson, MB, Schaefer, K. (1993). Conjunctivitis of allergic origin: immunologic mechanisms and current approaches therapy. Surv Ophthalmol. 38. 115-132
  • Anderson, DF. (2001). Management of seasonal allergic conjunctivitis (SAC): current therapeutic strategies. Clin Exp Allergy. 31. 823-826
  • Martin, AP, Urrets-Zavalia, J, Berra, A, Mariani, A, Gallino, N, Demel, E. (2003). The effect of ketotifen on inflammatory markers in allergic conjunctivitis: an open, uncontrolled study. BMC Ophthalmol. 3. 2
  • Abelson, MB, Chapin, MJ, Kapik, BM, Shams, NB. (2003). Efficacy of ketotifen fumarate 0.025% ophthalmic solution compared with placebo in the conjunctival allergen challenge model. Arch Ophthalmol. 121. 626-630
  • Schoch, C. (2003). In vitro inhibition of human conjunctival mast-cell degranulation by ketotifen. J Ocul Pharmacol Ther. 19. 75-81
  • Crampton, HJ. (2002). A comparison of the relative clinical efficacy of a single dose of ketotifen fumarate 0.025% ophthalmic solution versus placebo in inhibiting the signs and symptoms of allergic rhinoconjunctivitis as induced by the conjunctival allergen challenge model. Clin Ther. 24. 1800-1808
  • D'Arienzo, PA, Leonardi, A, Bensch, G. (2002). Randomized, double-masked, placebo-controlled comparison of the efficacy of emedastine difumarate 0.05% ophthalmic solution and ketotifen fumarate 0.025% ophthalmic solution in the human conjunctival allergen challenge model. Clin Ther. 24. 409-416
  • Greiner, JV, Michaelson, C, McWhirter, CL, Shams, NB. (2002). Single dose of ketotifen fumarate .025% vs 2 weeks of cromolyn sodium 4% for allergic conjunctivitis. Adv Ther. 19. 185-193
  • Friedlaender, MH. (1991). Current concepts in ocular allergy. Ann Allergy. 67. 5-10
  • Goodin, DS. (1999). Survey of multiple sclerosis in northern California. Mult Scler. 5. 78-88
  • Paganini-Hill, A, Chao, A. (1993). Accuracy of recall of hip fracture, heart attack, and cancer: a comparison of postal survey data and medical records. Am J Epidemiol. 138. 101-106
  • Kremer, B, Klimek, L, Bullinger, M, Mosges, R. (2001). Generic or disease-specific quality of life scales to characterize health status in allergic rhinitis?. Allergy. 56. 957-963
Fuente de los datos: Dialnet